Nigel Howard’s practice focuses on technology, outsourcing, and intellectual property issues. He represents clients in complex technology transactions, including outsourcing, licensing, corporate partnering, and strategic alliance transactions. Mr. Howard also has experience representing clients during IP property purchases and sales, and in reviews of IP portfolios in relation to corporate financing and merger and acquisition transactions. His experience includes cross-border technology transfers, development and testing arrangements, distribution channels, technology deployment, and electronic commerce as well as privacy laws with regard to electronic databases and online services.
On December 7, FDA published the much-anticipated “Framework for FDA’s Real-World Evidence Program” for drugs and biological products (the “Framework”). In a statement announcing the Framework, Commissioner Gottlieb recognized the opportunities and challenges of using real-world data (“RWD”) and real-world evidence (“RWE”) to enhance regulatory decision-making and noted that leveraging this information is “a top … Continue Reading
There are two papers in the May 15 volume of the Annals of Internal Medicine that discuss digital health applications and are illustrative of the topics being considered by physicians as they evaluate the adoption and impact of digital solutions. These papers serve as examples of the active dialogue taking place around the appropriate regulatory … Continue Reading
Technology companies widely use open source software (“OSS”), which carries with it many potential benefits. It can reduce the time and cost of development, and, to the extent that the code has been vetted by numerous other developers, may contain fewer bugs. OSS can also reduce dependency upon third party vendors and associated pricing risks. … Continue Reading
In the second of a three-part series, Covington’s global cross-practice Digital Health team considers some additional key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Commercial Questions When Contracting for Digital … Continue Reading
In the first of a three-part series, Covington’s global cross-practice Digital Health team answers key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle. Key Regulatory Questions About Digital Health Solutions 1. What are … Continue Reading
At the beginning of August, the D.C. Circuit found that the fact that a data breach has occurred and individual consumer information has been lost may constitute sufficient injury to confer standing on those individual victims at the pleading stage–irrespective of whether any stolen information has been misused. Specifically, Attias, et al. v. CareFirst, Inc., … Continue Reading